When is an expensive drug acceptable – when someone else pays?

The first modern epinephrine autoinjector, the EpiPen, was invented in the mid-1970s.Since then, many versions have been introduced but the market is still dominated by a single design, sold by Mylan.

Since Mylan acquired the product from Merck, its dominance of the US market has solidified around 90%. At the same time the price has dramatically risen – from $100 (wholesale price of 2 pens) in 2009 to a massive $610 this summer.

Mylan has been particularly active in encouraging the sale of its product into US schools – even being instrumental in introducing laws in at least 10 states that require the product in hotels, restaurants and other places. It is also helping push legislation pending in Congress that would require epinephrine auto-injectors on all commercial airline flights.

After Gayle Manchin took over the National Association of State Boards of Education in 2012, she spearheaded an unprecedented campaign to encourage states to force schools to buy stocks of medical devices that fight life-threatening allergic reactions.

I’m sure that the massive dominance of Mylan’s EpiPen in US schools will delight Gayle Manchin’s daughter – Heather Breasch, who is co-incidentally the CEO of Mylan.

The huge price hike has not gone unnoticed...

When Martin Shkreli tried to profiteer from HIV patients, he became one of the most hated figures on the internet. Whilst his 5,000% price rise makes Mylan’s 600% increase seem almost modest – he wasn’t up against the combined might of America’s parents!

Have Mylan, like Shkreli, offered to drop the price?

Mylan has announced more rebates for some patients and it is preparing to release a less expensive generic version. However, this isn’t the entire story.

There are now several independent voices actively lobbying to have the EpiPen added to a federal list of “preventative” medical services. This would mean that in many cases, the cost would be paid by insurers, employers or the government – rather than the patients themselves.

So who are these independent lobbyists?

Dr Leonard Fromer, an assistant clinical professor of family medicine at the University of California, has suggested the idea in an article in the American Journal of Medicine. The article was “drafted and revised” by a medical writing consulting firm paid by Mylan, in consultation with Dr Fromer, and he has served in the last year as a paid Mylan consultant.

Mylan also contributed money to many other groups behind the effort, and it has met with them — and The Allergy and Asthma Network in particular — to coordinate its strategy.

The decision about whether to class EpiPens a “preventive” drug will fall to the US Preventive Services Task Force, a federally appointed committee of physicians and experts.

Getting the designation could be difficult but Mylan has been particularly successful in influencing US government opinion in the past.